Safety & Regulatory Compliance Predictions For 2026: Unlock Safety & Regulatory Trends With IQVIA

In this live panel discussion, five IQVIA experts will examine the most critical safety and regulatory compliance shifts for 2026. Attendees will gain insights into AI’s real impact on regulatory operations and pharmacovigilance, the evolving stewardship role of medical information (MI) and how target product profiles (TPPs) can drive faster, smarter development decisions.

Attendees will leave with clear, actionable steps that can be applied immediately, including how to operationalize human-in-the-loop AI without compromising compliance, what to document and validate under the latest FDA guidance, how Local Qualified Persons for Pharmacovigilance (LQPPVs) should oversee vendor algorithms, the transparency standards MI teams must adopt and how TPPs can help pivot confidently amid uncertainty.

As regulatory frameworks continue to evolve, the conversation has shifted from “if” to “how” AI can augment the work of safety and regulatory professionals. For success in 2026, organizations should learn how to integrate AI transparently, maintain robust governance and unify decisions under shared strategic goals.

Register for this webinar to turn complexity into clarity and to learn how safety and regulatory compliance priorities are expected to shift through 2026.

Speakers

Michelle Gyzen, Senior Director, Strategic Regulatory Solutions; Head of Regulatory Services Innovation & Technology, IQVIA

Michelle has over 20 years of experience in the pharmaceutical, biotech and medical device industries. She is a Senior Director with expertise in designing large-scale regulatory outsourcing programs, offshore resource modeling and regulatory tech integration and automation. In her current role, Michelle is involved in designing strategic solutions for regulatory compliance, with a focus on operational efficiency, scalability and technology.

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Archana Hegde, Senior Director, PV Systems & Innovations, Lifecycle Safety, IQVIA

Archana Hegde joined IQVIA in 2015 and has held various leadership roles implementing technology solutions to support critical business processes. In her current role, she provides senior leadership and oversight for the Safety Tech-Service Integrated Offering delivery, combining IQVIA’s expertise from a technology and service perspective while focusing on accuracy, efficiency, compliance, standardization and automation.

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Ian Fisher, Head of Development Analytics, Regulatory Affairs and Drug Development Solutions, IQVIA

Ian Fisher leads a team of experienced analysts to provide drug developers with insights and direction for indication prioritization, target product profiles, clinical development planning and asset valuation. Fisher and his team leverage structured and instructed data and information within structured decision-making frameworks to increase the efficiency, transparency and success of strategic program development. Fisher has over 22 years of experience in drug development and holds two Master’s degrees in Chemistry and Health Economics.

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Louise Molloy, Associate Director Medical Information & Pharmacovigilance, IQVIA

Louise Molloy manages operations for the Medical Information and Pharmacovigilance team at IQVIA, focusing on optimizing processes and leveraging technology to enhance efficiency and compliance. Molloy is an integral part of the global team, advising pharmaceutical companies on best practices, innovation and automation in MI. She frequently speaks on topics such as integrating AI in Medical Information systems and the evolving landscape of pharmacovigilance. Located in Spain, Molloy brings over 15 years of experience in the pharmaceutical industry.

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Ana Pedro Jesuíno, Associate Director of Marketed Product Safety, IQVIA

Ana Pedro Jesuíno is the Marketed Product Safety Associate Director at IQVIA, with more than ten years of pharmacovigilance experience, including both CRO and pharmaceutical industries. She has oversight of IQVIA’s Local QPPV Global Network and holds a Master’s degree in Pharmaceutical Sciences.

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